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Friday, 30 December 2011

Stricter Cosmetic Surgery Regulations Suggested – The GHS Perspective

Article by
Kevin Timms

The 30,000 women in France who have been recommended to have their PIP breast implants removed as a result of inherent defects in the breast implants has left up to 40,000 to 50,000 women in the UK unnecessarily in fear as a result of the MHRA and other UK authorities stating there are no health risks associated with PIP breast implants.

MPs are now suggesting that, as a result of the PIP breast implant scandal, cosmetic surgery patients could be put on a database to help prevent another scare like this.

Apparently Andrew Lansley, the Health Secretary, has been urged to take action and he will now look into the concerns that women have been provided with unsatisfactory breast implants.

The Sun has reported that Stephen Dorrell, Chairman of the Commons health select committee, wants manufacturers and suppliers to be compelled to keep records, of who received their products, as part of their licence to operate in Britain. In an interview with The Times he said “This is a product being put into a human body – it should have a proper audit trail for when and where it is used”.

Garden House Solicitors have been acting on behalf of women with PIP breast implants since early 2010 when the PIP breast implant scandal was first unearthed. It was the MHRA which released the Medical Device Alert on 31 March 2010 warning of the potential harm these implants could cause following the AFSSAPS’ (French medical device regulators) finding that PIP breast implants have a premature rupture rate and that the silicone used was not authorised.

The MHRA has stated that there is no more of a health risk with PIP breast implants than with other silicone breast implants on the market. However, if this were so, why has the recent events surrounding the PIP breast implants pushed MPs into discussions about cosmetic surgery and medical device regulations?

Clearly, medical device regulation is due for reform – this is evident from the two major medical device recalls in 2010 which have affected thousands of individuals in the UK, namely, DePuy ASR hip implants and PIP breast implants. Both medical devices were introduced to the UK market without clinical trials.

When comparing medical devices such as breast implants and hip implants with pharmaceutical drugs the gap between how each sector is regulated is immense, yet both are invasive and used with humans.

Women in the UK have been patiently waiting for the UK authorities to put a policy into place to protect them from the problems with PIP breast implants. To start, the long awaited test results from AFSSAPS took a considerable time. However, this was worth the wait as AFSSAPS, through diligent and extensive testing, have shown that PIP breast implants are defective by reason of their design and also in respect of the breast implant mechanical and physical properties. There was also a considerable wait for the MHRA tests. However, the MHRA test results were welcoming and reassuring to women that PIP breast implants are not associated with cancer. However, these tests did not extend as far as to examine the non toxic properties of PIP breast implants. Until they do so, it would appear that the evidence from France is more reliable.

Garden House Solicitors have written to the MHRA asking precise questions as to what testing carried out by AFSSAPS they agree with and what they do not agree with. To date, we still await a response. It is necessary to establish exactly what the UK authorities position is with regards to the suitability of PIP breast implants.

The UK authorities present advice to women with PIP breast implants has been based on the adverse incident reports received by the MHRA. However, it is unclear how accurate these have been. Some women have informed Garden House Solicitors that they have completed adverse incident reports but have not been made aware if the reports were ever processed and other women have suffered from a rupture prior to the recall of PIP breast implants without being advised of whether an adverse incident report should be completed. This again suggests that cosmetic surgery and medical devices need stricter regulation.

Garden House Solicitors act on behalf of a number of women who are bringing claims against their PIP breast implant provider for compensation for the cost of revision surgery, personal injuries sustained as a result of problems with PIP breast implants and associated financial losses. We have been particularly concerned that many women are probably unaware that they have PIP breast implants and are concerned that nobody has a clear idea of how women in the UK are affected by PIP breast implants. We have therefore set up a National PIP Breast Implant Register.

The National PIP Breast Implant Register is aimed at establishing approximately how many women have suffered from ruptures or experienced adverse symptoms as a result of PIP breast implants. The information is more detailed that one would normally expect from an implant register and this is to establish whether PIP breast implants and their silicone is likely to have a more severe effect on a particular individual.

Whilst we commend the suggestion of a Cosmetic Surgery Register, we are presently concerned with our clients and all the other women with PIP breast implants which is why we have compiled the National PIP Breast Implant Register – a Register dedicated to those with PIP breast implants. To register with the National PIP Breast Implant Register please go to www.pipbreastimplantregister.co.uk and a member of our PIP team will contact you.

The National PIP Breast Implant Register is completely separate from the PIP breast implant group action in the High Court we are currently pursuing and from the other claims we have been instructed to make. However, it is looking increasingly more likely that the way in which women with PIP breast implants will be able to recover the costs of revision surgery and seek compensation for personal injuries they have sustained as a result of their PIP breast implants being faulty, is by pursuing a compensation claim against their implant provider.

If you have had PIP breast implants provided within the last six years or you have become aware of adverse symptoms as a result of your PIP breast implants within the last three years you are likely to be entitled to compensation. Please contact Kevin Timms at Garden House Solicitors to discuss your PIP Breast Implant Compensation Claim. Kevin can be contacted on 01992 422 128 or at kevin@gardenhousesolicitors.co.uk. Our clients are based all over the UK.

If however, you have sustained an injury as a result of problems with you PIP Breast Implants we might still be able to make a PIP Breast Implant Compensation Claim on your behalf. It is unfortunate that not everyone will be able to make a claim but if your clinic is still solvent we would be happy to investigate an injury claim if you suffered an injury, such as a rupture, over three years go.

A number of women may not be entitled to make a claim because their clinic is either dissolved or has recently fallen into liquidation. However, Garden House Solicitors is currently investigating potential ways around this and it is still possible for some people whose clinic has previously dissolved to make a claim. We are making a concerted effort to investigate other avenues so a path has been set to ensure as many women as possible can recover the costs of revision surgery and compensation for injuries where they have been sustained.

2 comments:

i so hope you can help me, i had pip implants in 2004 - i have always experinced pain but thought it was due th them bing under the muscle - i had a ruptured implant detected this year - june 2011 & had to have implants removed & replaced which cost me near on £4'000 my worry now is the pain ive got which i belived is down to the free industrial silicone that is left in my breast tissue & lymph nodes . . . sick with worry - i really hope you can help me... Vikki

Thank you for your comment. I am sorry to hear you are still suffering after revision surgery. I am quite sure you may have already put your name forward for the National PIP Breast Implant Register and we are contacting people back as soon as possible. However,if you have more immediate concern please feel free to contact me directly at the office on 01992 422 128 or email me at kevin@gardenhousesolicitors.co.uk. I may not be in the office on Tuesday but will be checking emails regularly.